Utility of Sodium Lactate Infusion During Septic Shock

Last updated: August 16, 2022
Sponsor: University Hospital, Lille
Overall Status: Active - Recruiting

Phase

2/3

Condition

Sepsis And Septicemia

Low Blood Pressure (Hypotension)

Treatment

N/A

Clinical Study ID

NCT03528213
2015_56
2017-002393-39
  • Ages > 18
  • All Genders

Study Summary

ULIS-1 is an open-label pilot study concerning utility of molar sodium lactate in fluid balance in septic shock patients

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Presence of septic shock
  • requiring vascular filling within 12 hours after introduction of Noradrenaline. Septicshock is defined as sepsis with persistent hypotension requiring the administration ofvasopressors to maintain RTE > 65mmHg.
  • social insurance

Exclusion

Exclusion Criteria:

  • pregnancy
  • cardiac arrest
  • more than 50ml/kg of fluid loading
  • chronic renal failure with chronic hemodialysis or the investigators estimate a needfor renal replacement therapy in the following 24hrs
  • child C or acute liver failure with PT<40% (unless AVK)
  • plasmatic sodium <120 or >145mmol/l
  • metabolic alkalosis with pH>7.45

Study Design

Total Participants: 90
Study Start date:
October 04, 2019
Estimated Completion Date:
November 30, 2023

Study Description

ULIS-1 consists in three arms of treatment during the first 24hrs of septic shock treatment.

  • normal saline

  • sodium lactate 2.5ml/kg in 60min then

  • either 0.25 or 0.5ml/kg/h during 24hrs Main criteria is fluid balance at 48hrs

Connect with a study center

  • CH ARRAS

    Arras,
    France

    Active - Recruiting

  • CH DOUAI

    Douai,
    France

    Active - Recruiting

  • Ch Dunkerque

    Dunkerque,
    France

    Active - Recruiting

  • CH LENS

    Lens,
    France

    Active - Recruiting

  • Hôpital Roger Salengro, CHU

    Lille,
    France

    Active - Recruiting

  • Hopital Victor Provo - Roubaix

    Roubaix,
    France

    Active - Recruiting

  • Chu Rouen

    Rouen,
    France

    Active - Recruiting

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